FDA Adverse Event
Injury
Summary report: N
GORE PROPATEN VASCULAR GRAFT
MDR report key: 1912702
·
Received November 24, 2010
Report
- Report Number
- 2017233-2010-00528
- Event Type
- Injury
- Date Received
- November 24, 2010
- Date of Event
- August 19, 2009
- Report Date
- November 23, 2010
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- PMA / PMN Number
- K062161
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2009, A BYPASS PROCEDURE WAS PERFORMED IN THE LEFT LEG USING 6MM GORE PROPATEN VASCULAR GRAFT, FROM THE SUPERFICIAL FEMORAL TO POSTERIOR TIBIAL ARTERY. ON (B)(6) 2009, A FAILED GRAFT REQUIRED A THROMBOLYSIS AND A REVISION. AN ANGIOPLASTY WAS ALSO PERFORMED FOR A DISTAL STENOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE PROPATEN VASCULAR GRAFT | DSY/PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | DSY | W.L. GORE & ASSOCIATES | WLG450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |